Fluid temperature control system

ABSTRACT

Described herein is a system for heating and/or cooling a fluid that includes a temperature forcing device having a bottom plate and a top plate hingedly coupled to the bottom plate. At least one of the bottom plate and the top plate has a recess or other area for receiving at least one flexible fluid holder (e.g., a polymer bag). The bottom plate and/or top plate also has at least one protrusion and/or recession in its interior wall(s) such that a fluid passageway in the flexible fluid holder is defined when the fluid holder is placed between the top and bottom plates, and the plates are closed together. The fluid holder then has a fluid inlet for receiving the fluid to be heated and/or cooled and a fluid outlet for delivering the fluid. The fluid, upon being heated and/or cooled by the temperature forcing device, may then be delivered to a patient or may be delivered to another system component, e.g., for additional heating/cooling.

RELATED APPLICATIONS

This application claims priority to U.S. Provisional Application No.62/888,301 filed on Aug. 16, 2019, U.S. Provisional Application No.62/891,156 filed on Aug. 23, 2019, and U.S. Provisional Application No.62/948,717 filed on Dec. 16, 2019, the entire contents of each of whichare hereby incorporated by reference.

FIELD

The subject matter described herein relates to systems and methods forheating and cooling fluids, particularly for use in health care.

BACKGROUND

In modern health care systems and treatment methodologies, therapeuticfluids such as blood, saline, crystalloids, and dialysate often requirea temperature adjustment (heating and/or cooling) prior to beingdelivered to a patient. Treatments sometimes include adjustments ofpatient's body temperature using temperature management devices.Temperature adjustments are often performed by using a resistance heaterto warm a heat transfer fluid and a refrigeration system to cool thesame heat transfer fluid as required. The heat transfer fluid may thenbe pumped through a heat exchanger where the thermal energy istransferred into or out of the therapeutic fluid and/or temperaturemanagement device.

Other systems may utilize a solid-state heater/cooler device to performboth the heating function as well as the cooling function, via the heattransfer fluid. In these systems, the heat transfer fluid is pumped tothe heat exchanger where the thermal energy is transferred to thetherapeutic fluid.

One disadvantage of these methods and systems is that the heat transferfluid typically operates at temperatures at (or near) the normothermictemperature (i.e., 98.6 degrees Fahrenheit), which makes it particularlysusceptible to the growth, incubation, and proliferation of bacteria,thereby exposing the patient to increased risk of infection. For suchmethods and systems, high temperature (e.g., temperature higher than121° C.) and/or a disinfecting solution is needed to limit growth, whichcan cause damage to machines.

Another disadvantage of existing systems is the incidental mixing of theheat transfer fluid with the therapeutic fluid, which may result inbacterial contamination of the system and/or increased risk to thepatient. In addition, existing fluid heating systems may employ flexiblebags that contain fluid passageways defined by welded channels in theform of a serpentine fluid path. Existing systems may also warm blood byinserting blood via a cartridge into a closed, narrow, slotted chamber.Due to the closed nature of such narrow, slotted chambers, cleaning andfluid leakage detection may be difficult, resulting in sterilizationchallenges. Additionally, as existing fluid heating systems may not beable to open easily, it is challenging to visualize whether cleaning isnecessary.

SUMMARY OF THE INVENTION

Described herein is a system for heating and/or cooling a fluid thatincludes a temperature forcing device having a bottom plate and a topplate hingedly coupled to the bottom plate. At least one of the bottomplate and the top plate has a recess or other area for receiving atleast one fluid holder. The system also includes at least one flexiblefluid holder. In certain embodiments, the flexible fluid holdercomprises a plastic bag comprising polyvinyl chloride (PVC) and/or otherpolymer(s) such as ethylene vinyl acetate (EVAM), polypropylene, and/orcopolyester ether, for example. The fluid holder has a fluid inlet forreceiving the fluid to be heated and/or cooled and a fluid outlet fordelivering the fluid. The fluid, upon being heated and/or cooled by thetemperature forcing device, may then be delivered to a patient or may bedelivered to another system component, e.g., for additionalheating/cooling. In some embodiments, the system component directly,physically contacts the body of a patient for managing a bodytemperature of the patient. For example, in some embodiments, the systemcomponent is a blanket, wrap, or mattress containing the fluid. In someembodiments, the fluid is a therapeutic fluid. For example, in someembodiments, the fluid is a therapeutic fluid and the system operateswithout the need for a heat transfer fluid. In some embodiments, thefluid is a heat transfer fluid. In some embodiments, the fluid beingheated and/or cooled (e.g., the therapeutic fluid or the heat transferfluid) does not directly contact the temperature forcing device suchthat the temperature forcing device has less risk of harboring pathogenswithin a healthcare environment. In some embodiments, the fluid path andremaining fluid can be entirely disposed, thereby reducing risk ofcontamination of the temperature forcing device.

In some embodiments, the top plate and/or the bottom plate include(s) atleast one recession and/or at least one protrusion for creating a fluidpassageway between the top plate and the bottom plate upon closure ofthe device. Closure means the top plate and bottom plate are broughtinto proximity of each other (e.g., touching or not touching) via ahinge coupling the top and bottom plates. In the closed position, thetop and bottom plates may touch each other along an edge, protrusion,and/or at another/other location(s). Upon closure of the device, a fluidpassageway is defined in the flexible fluid holder by the at least onerecession and/or at least one protrusion in (an) interior wall(s) of thetop and/or bottom plates, said fluid holder having been inserted betweenthe plates prior to closure of the device (e.g., said fluid holderhaving been placed within or on the recess or other area of the bottomor top plate prior to closure). In certain embodiments, the passagewaydefines a distinct channel between an inlet and an outlet of the fluidholder (e.g., pre-welded). In certain embodiments, the fluid passagewayis only formed when the device is in a closed state, otherwise the fluidholder does not have a passageway defining a distinct channel between aninlet and an outlet of the fluid holder.

In some embodiments, the temperature forcing device is capable of bothcooling and heating the fluid. In some embodiments, the temperatureforcing device includes a solid state device (e.g., a Peltier deviceand/or a thermoelectric cooler). In some embodiments, the temperatureforcing device includes a resistive heater. In some embodiments, thetemperature forcing device includes a compressor. In some embodiments,the temperature forcing device may include at least one fin disposed inat least one of the bottom plate and/or the top plate.

In some embodiments, the system includes at least one latch disposed inor on at least one of the bottom plate and the top plate or in or on asupport or housing for at least one of the bottom plate and the topplate.

In some embodiments, the system has at least one fluid holder mounted toa mounting sheet.

In some embodiments, the system has at least one fluid holder (e.g., andmounting sheet) shaped and sized to be inserted into the device andremoved therefrom.

In some embodiments, the system includes at least one power supplyelectrically coupled to a resistive heater disposed within or upon orunder at least one of the top plate and the bottom plate. In someembodiments, the system includes at least one power supply electricallycoupled to a solid state device (e.g., a Peltier device and/or athermoelectric cooler, e.g., a dry solid state device) disposed withinor upon or under at least one of the top plate and the bottom plate.

In some embodiments, the system includes at least one pin protrudingfrom the bottom plate and/or the top plate, wherein each of the at leastone pins is inserted through a corresponding hole in the fluid holderand/or its mounting sheet to secure the fluid holder and/or its mountingsheet when positioned within the temperature forcing device.

In some embodiments, the system is free from any heat transfer fluid.

In some embodiments, the temperature forcing device has a maximumoperating temperature (e.g., the maximum controlled temperature of thefluid) from about 40 degrees C. to about 60 degrees C., or from about 40degrees C. to about 50 degrees C., or from about 40 degrees C. to about45 degrees C. In some embodiments, the temperature forcing device has anoperating temperature range (e.g., a range of controlled temperature ofthe fluid) that encompasses the range from about 1 degrees C. to about60 degrees C., or from about 20 degrees C. to about 50 degrees C., orfrom about 30 degrees C. to about 45 degrees C.

In some embodiments, the system accommodates (e.g., permits) a maximumflow rate through the temperature forcing device of from about 5 L/minto about 15 L/min, or from about 7 L/min to about 13 L/min, or fromabout 9 L/min to about 12 L/min.

In some embodiments, the therapeutic fluid includes at least one ofblood, crystalloid and dialysate.

In some embodiments, the heat transfer fluid is selected from the groupconsisting of water, saline, oil, silicone fluid, propylene glycol, anda combination thereof.

Also described herein is a flexible fluid holder for containing a fluid(e.g., a therapeutic fluid or a heat transfer fluid), said fluid holderincluding: a fluid inlet, allowing the fluid to flow into the fluidholder; a fluid outlet allowing the fluid to flow out of the fluidholder; and at least one fluid passageway in the fluid holder fluidlyconnecting the fluid inlet to the fluid outlet. In certain embodiments,the fluid passageway is defined by a top plate and/or a bottom plate ofa solid-state device into which the fluid holder is inserted, saidpassageway formed upon closure of the top plate and bottom plate.

In some embodiments, the top plate and/or the bottom plate include atleast one recession and/or at least one protrusion (e.g., for creatingsaid passageway upon closure of the top plate and bottom plate, e.g.,said top plate and bottom plate brought into proximity or touching alongan edge upon closure).

In another embodiment, a fluid holder for containing a therapeutic fluidincludes a fluid inlet, allowing the therapeutic fluid to flow into thefluid holder; a fluid outlet allowing the therapeutic fluid to flow outof the fluid holder; and at least one fluid passageway disposed withinthe fluid holder fluidly connecting the fluid inlet to the fluid outlet.The fluid passageway is defined by at least one protrusion and/or atleast one recession in the interior walls of a solid-state device intowhich the fluid holder is inserted (e.g., said passageway formed whenthe device is in a closed state).

Also described herein is a method of adjusting the temperature of afluid that includes: providing a temperature forcing device having abottom plate and a top plate hingedly coupled to the bottom plate. Atleast one of the bottom plate and the top plate comprises an area (e.g.,a recess) disposed therein or thereupon for receiving a flexible fluidholder (e.g., plastic bag) through which fluid to be heated and/orcooled will flow. The top plate and/or the bottom plate comprise(s) atleast one recession and/or at least one protrusion for creating a fluidpassageway between the top plate and the bottom plate upon closure ofthe temperature forcing device, said fluid passageway defining a channelbetween a fluid inlet and a fluid outlet of the flexible fluid holder.The top plate and/or the bottom plate may comprise a solid state deviceand/or a resistive heater and/or a heater exchanger from a compressioncycle disposed therewithin, thereupon, or thereunder. The method furtherincludes: inserting a fluid holder between the bottom plate and the topplate; positioning the top plate proximate the bottom plate (e.g.,thereby forming a channel along which fluid may flow within the fluidholder from an inlet to an outlet, said channel formed due to ridges,grooves, and/or other textural features of the top plate and/or thebottom plate); delivering the fluid to a fluid inlet disposed in thefluid holder; and delivering power to at least one power supplyelectrically coupled to the temperature forcing device in order toadjust the temperature of the fluid as it flows from the fluid inlet tothe fluid outlet of the flexible fluid holder between the top plate andthe bottom plate of the temperature forcing device. The method mayinclude implementing one or more features of the system embodimentsdescribed herein.

Throughout the description, where an apparatus, systems or compositionsare described as having, including, or comprising specific components,or where methods are described as having, including, or comprisingspecific steps, it is contemplated that, additionally, there are systemsor compositions of the present invention that consist essentially of, orconsist of, the recited components, and that there are methods accordingto the present invention that consist essentially of, or consist of, therecited processing steps.

It should be understood that the order of steps or order for performingcertain action is immaterial so long as the invention remains operable.Moreover, two or more steps or actions may be conducted simultaneously.

The following description is for illustration and exemplification of thedisclosure only, and is not intended to limit the invention to thespecific embodiments described.

The mention herein of any publication, for example, in the Backgroundsection, is not an admission that the publication serves as prior artwith respect to any of the claims presented herein. The Backgroundsection is presented for purposes of clarity and is not meant as adescription of prior art with respect to any claim.

BRIEF DESCRIPTION OF THE DRAWING

A full and enabling disclosure of the present disclosed embodiments,including the best mode thereof, directed to one of ordinary skill inthe art, is set forth in the specification, which makes reference to theappended figures, in which:

FIG. 1 illustrates an exemplary top view depiction of a disposable bagwith an integral, welded-in serpentine fluid path;

FIG. 2 illustrates an exemplary perspective view depiction of adisposable bag with an integral, welded-in serpentine fluid path;

FIG. 3 illustrates a perspective view depiction of a solid-state drytemperature control system with a built-in integral fluid path andhinged opening in a closed configuration, according to an illustrativeembodiment;

FIG. 4 illustrates a perspective view depiction of a solid-state drytemperature control system with a built-in integral fluid path andhinged opening in an open configuration, according to an illustrativeembodiment;

FIG. 5 depicts an empty fluid holder that may be used with thesolid-state dry temperature control system of FIGS. 3 and 4 , accordingto an illustrative embodiment;

FIG. 6 depicts a full fluid holder that may be used with the solid-statedevice described herein;

FIG. 7 illustrates a perspective view depiction of a solid-state drytemperature control system with a built-in integral fluid path andhinged opening in an open configuration, according to an illustrativeembodiment;

FIG. 8 illustrates a front view of a solid-state dry temperature controlsystem with a built-in integral fluid path and hinged opening in an openconfiguration, according to an illustrative embodiment;

FIG. 9 illustrates a flow chart representation of a method of heatingand/or cooling therapeutic fluid using the solid-state device, inaccordance with aspects of the present disclosed embodiments;

FIG. 10 illustrates a temperature forcing device in a system for heatingand/or cooling a fluid, according to an illustrative embodiment;

FIG. 11 illustrates a view of the temperature forcing device of FIG. 10showing the inlet and outlet of the fluid path formed when the top andbottom plates are closed, according to an illustrative embodiment;

FIG. 12 illustrates a front view of the temperature forcing device ofFIG. 10 , according to an illustrative embodiment;

FIG. 13 illustrates a side view of the temperature forcing device ofFIG. 10 , according to an illustrative embodiment;

FIG. 14 illustrates a top view of the temperature forcing device of FIG.10 when the device is closed, according to an illustrative embodiment;

FIG. 15 illustrates a flexible fluid holder (disposable bag) with afluid path formed by the temperature forcing device of FIG. 10 when thedevice is closed, according to an illustrative embodiment;

FIG. 16 illustrates a flexible fluid holder (disposable bag) without afluid path formed (e.g., when not in the temperature forcing device ofFIG. 10 ), according to an illustrative embodiment;

FIG. 17 illustrates a direct fluid warming and/or cooling system withfluid flow provided by gravity, according to an illustrative embodiment;

FIG. 18 illustrates a direct fluid warming and/or cooling system withpump assist, according to an illustrative embodiment; and

FIG. 19 illustrates a conditioned fluid warming and/or cooling system,according to an illustrative embodiment.

DESCRIPTION OF THE INVENTION

Reference will now be made in detail to the present disclosedembodiments, one or more examples of which are illustrated in theaccompanying drawings. The detailed description uses numerical and/orletter designations to refer to features in the drawings. Like orsimilar designations in the drawings and description have been used torefer to like or similar parts of the present embodiments.

Some embodiments of the present disclosure provides systems and methodsfor heating and cooling therapeutic fluids, utilizing a dry, solid-stateheating and cooling device that does not employ a heat transfer fluid.The solid-state system of the present embodiments is “dry” because itdoes not use a heat transfer fluid (such as glycol, water, etc.) totransfer heat into and out of the therapeutic fluid. However, in otherembodiments, systems and methods of the present disclosure may be usedfor heating and/or cooling heat transfer fluids. The system may includea hinge to ease the placement and removal of the bag. The system mayalso include a plurality of fins to aid in heat transfer. In addition,the system may include one or more latches to ensure the solid stateheating and cooling device remains closed while in operation. FIG. 1illustrates a top view of an exemplary fluid holder 10 including a fluidinlet 12, a fluid outlet, 14, serpentine passages 16, and a mountingplate 18 to which the serpentine passages 16 are welded.

FIG. 2 illustrates a perspective view of the exemplary fluid holder ofFIG. 1 . In both FIGS. 1 and 2 , the fluid entering and exiting thefluid holder is a heat transfer fluid, not a therapeutic fluid such asblood and/or dialysate. The exemplary embodiments of FIGS. 1 and 2 wouldalso include other heat exchangers (not shown) in order to transfer heatfrom the heat transfer fluid into the therapeutic fluid and/ortemperature management device, or vice versa.

FIG. 3 illustrates a perspective view of a solid-state device 20according to the present embodiments. In the depiction shown in FIG. 3 ,the solid-state device 20 is in a closed position. The solid-statedevice 20 may include a fluid inlet 22 for receiving a therapeutic fluid(such as blood or dialysate) from a patient and/or pump, as well as afluid outlet 24, for delivering a heated and/or cooled fluid back to thepatient. Each of the fluid inlet 22 and fluid outlet 24 are fluidlycoupled to a fluid holder 44 (not shown) which in the embodiment of FIG.3 is within the solid-state device 20. As such, each of the fluid inlet22 and fluid outlet 24 are inserted into the solid-state device 20 whenthe fluid holder 44 (not shown) is inserted into the solid-state device20. Each of the fluid inlet 22 and fluid outlet 24 may includecylindrical tubing that may be fluidly connected to other system tubingand/or components via various connection mechanisms (e.g., nipples,couplings, valves, elbows, unions, tees, male and female adaptors,compression fittings, face seal fittings, bard tubed fittings, quickdisconnect fittings, and other suitable fluid coupling mechanisms). Thesolid-state device 20 may include a top plate 26 and a bottom plate 28,the top and bottom plates 26, 28 being hingedly coupled via one or morehinges 30. In some embodiments, the one or more hinges 30 will beproximate the fluid inlet 22 while in other embodiments the one or morehinges 30 will be proximate the fluid outlet 24. The one or more hinges30 allow the top plate 26 to rotate open about the hinge 30 therebyproviding space between the top plate 26 and the bottom plate 28 toallow the fluid holder 44 (not shown) to be inserted. In someembodiments, the one or more hinges 30 may be located at the oppositeside of the fluid inlet 22 and the fluid outlet 24. In some embodiments,the solid-state device 20 further comprises a blood detector, fluidtemperature sensors (e.g., resistive, infrared, fiber optic temperaturesensor), a pressure transducer, patient temperature probes, an airdetector (e.g., ultrasonic sensor detecting air in fluid), and/or afluid flow rate detector.

Referring still to FIG. 3 , the solid-state device 20 may include a topinlet recess 32A and a bottom inlet recess 32B which each may includecontours and/or recesses disposed within each of the top plate 26 andthe bottom plate 28 to allow the fluid inlet 22 to act as a fluidconduit through the top and bottom inlet recesses 32A, 32B while thesolid-state device is in a closed position. Similarly, the solid-statedevice 20 may also include a top outlet recess 34A and a bottom outletrecess 34B which each may include contours and/or recesses disposedwithin each of the top plate 26 and the bottom plate 28 to allow thefluid outlet 24 to act as a fluid conduit through the top and bottomoutlet recesses 34A, 34B while the solid-state device is in a closedposition. The top inlet recess 32A and the bottom inlet recess 32B mayeach be disposed proximate the fluid inlet 22 to allow fluids to enterthe solid-state device while the top outlet recess 34A and the bottomoutlet recess 34B may each be disposed proximate the fluid outlet 24 toallow fluids to exit the solid-state device. The solid-state device 20may also include one or more pluralities of fins 36 extending verticallyupward from the top plate 26 and extending vertically downward from thebottom plate 28. One or more spaces 38 may separate pluralities of fins36 from one another. Each fin may include a proximal portion 40 disposedclose to the respective top plate 26 or bottom plate 28, as well as adistal portion 42 extending away from the respective top plate 26 orbottom plate 28. In some embodiments, each fin of the plurality of fins36 may be thinner at the distal portion 42 than at the proximal portion40. Stated otherwise, each proximal portion 40 may be thicker than eachdistal portion 42. In other embodiments, each fin of the plurality offins 36 may have a uniform thickness from the proximal end 40 to thedistal end 42.

Still referring to FIG. 3 , the one or more plurality of fins 36 may bealigned widthwise (as shown in FIG. 3 ), lengthwise (not shown) or inhybrid configurations including one or more pluralities of fins 36aligned in widthwise, lengthwise, diagonal and/or other configurations.The one or more pluralities of fins 36 may also be oriented such thatthey extend away from the top and bottom plates 26, 28 at an angle(i.e., the plain defined through the center of each fin intersects theplain defined by the top plate 26 and/or bottom plate 28 at an angleother than 90 degrees). The solid-state device 20 may include variousnumbers of pluralities of fins 36 on each of the top plate 26 and bottomplate 28, as well as various numbers of fins within each plurality offins 36. For example, 3 pluralities of fins 36 each including 10 finsmay be disposed within each of the top and bottom plates 26, 28. Inother embodiments, from about 2 to about 4 pluralities of fins 36 eachincluding from about 8 to about 12 fins may be disposed within each ofthe top and bottom plates 26, 28. In other embodiments, from about 1 toabout 10 pluralities of fins 36 each including from about 1 to about 20fins may be disposed within each of the top and bottom plates 26, 28.Other embodiments may include other numbers of pluralities of fins 36 aswell as other numbers of fins within each plurality of fins 36. In someembodiments the top and bottom plates 26, 28 may have the same numberand arrangement of pluralities of fins 36 while in other embodiments thetop and bottom plates 26, 28 may have different numbers of pluralitiesof fins 36 and/or fin arrangements. The solid-state device 20 mayinclude one or more latches 42 for ensuring that the top plate 26 stayscoupled to the bottom plate 28 while the solid-state device 20 is inoperation. The one or more latches 42 may be hingedly coupled to the topplate 26 and/or the bottom plate 28. Other suitable mechanisms ofcoupling the top and bottom plates 26, 28 together as well as forcoupling the one or more latches 42 to the top and/or bottom plates 26,28 are also possible.

Referring still to FIG. 3 , the solid-state device 20 may be used forboth heating and cooling. Each of the top plate 26 and bottom plate 28may include one or more embedded resistance heaters (not shown) or oneor more Peltier heater/coolers and may be electrically coupled to one ormore power sources (not shown) in order to provide heating and/orcooling to the interior of the solid-state-device 20. For example, thetemperature forcing device disposed within each of the top and bottomplates 26, 28 may be configured as Peltier devices (or Peltier heatpump) allowing each of the top and bottom plates 26, 28 to provideheating and/or cooling to the interior of the solid-state device,depending on which direction current is flowing through the Peltierdevice. Each Peltier device and/or other temperature forcing device maybe used in connection with the one or more pluralities of fins 36 in usecases in which it is desirable to provide cooling to the interior of thesolid-state device 20. In addition, the one or more pluralities of fins36 may provide passive cooling to the interior of the solid-state device20 since room temperature (usually between 55 degrees Fahrenheit and 85degrees Fahrenheit) is often less than the normothermic temperature ofabout 98.6 degrees Fahrenheit (+/−2-3 degrees Fahrenheit). The geometryof the fins, the materials the fins are compose of, the number of fins,the groupings of fins, the spacing between fins and the orientations ofthe fins may be varied to enhance the heat transfer effectiveness of thesolid-state device 20. The solid-state device 20 may provide coolingand/or heating to the therapeutic fluid without the need for a dedicatedheat transfer fluid or any moving parts. In some embodiments, resistanceheating elements and pluralities of fins 36 may be disposed within boththe top and bottom plates 26, 28. In other embodiments, resistanceheating elements and/or pluralities of fins 36 may be disposed in eitherthe top plate 26 or bottom plate 28, but not both. The pluralities offins 36 may be composed of a different material or materials than thatof the top and bottom plates 26, 28 in order to enhance heat transfer.The solid-state device 20 may also include a fan (not shown) to increasethe flow of air across the one or more pluralities of fins 36.

FIG. 4 illustrates a perspective view of the solid-state device 20 in anopen position with a fluid holder 44 placed within. In the embodiment ofFIG. 4 , the one or more latches 42 have been released and the top plate26 has been rotated about the hinge 30 into an open position, allowingthe fluid holder 44 to be placed within the solid-state device 20. Thefluid holder 44 may include a first portion 46 proximate the fluid inlet22 and a second portion 48 proximate the fluid outlet 24. Between thefirst portion 46 and the second portion 48, the fluid holder may includea rounded portion 45 at the opposite side of the solid-state device 20.The fluid holder 44 may include a mounting sheet 60 which helps toensure both that the fluid holder 44 is positioned in precisely thecorrect location within the solid-state device 20, and also to ensure aneven distribution of heat transfer from the solid-state device 20 intothe fluid holder 44. The solid-state device may include first and secondpins 50, 52 which may protrude upwardly from a top surface 29 of thebottom plate 28 through openings in the mounting sheet 60 to ensure thefluid holder 44 is accurately positioned within the solid-state device20.

FIG. 4 further illustrates an inlet coupling 53 circumferentiallydisposed around one end of the fluid inlet 22 as well as an outletcoupling 55 circumferentially disposed around a fluid outlet 24. Each ofthe inlet coupling 53 and the outlet coupling 55 form the respectivetransitions between the interior of the fluid holder 44 and the fluidinlet 22 and/or fluid outlet 24. The inlet coupling 53 and the outletcoupling 55 may each include a diameter that is slightly greater thanthe fluid inlet 22 and outlet 24 such that the fluid inlet 22 and outlet24 may be rigidly inserted into the inlet coupling 53 and the outletcoupling 55 via a compression fit and/or other mechanisms (epoxy,adhesion, sintering, adjustable hose clamp and/or ring clamp). The inletand outlet couplings 53, 55 may be composed of a material that is harderand/or more rigid than the fluid inlet 22 and fluid outlet 24 (as wellas any associated tubing to which the fluid inlet and outlet 22, 24 areconnected) such that the inlet and outlet couplings 53, 55 help tosupport the weight of the top plate 26 (and any compression associatedwith the latches 42 when the solid-state device is closed). For example,as the top plate 26 comes to rest on top of the bottom plate 28, therecessed portions 32A, 34A of the top plate 26 will come in contact withand/or interface with the inlet and outlet couplings 53, 55, therebyallowing the weight and/or downward force of the top plate to bedistributed across the inlet and outlet couplings 53, 55 (as well as thefirst and second pins 50, 52.) The height of the first and second pins50, 52 (as well as the diameters of the inlet and outlet couplings 53,55) may be designed such that the spacing between the top and bottomplates 26, 28 is optimal from an operational point of view when thesolid-state device 20 is in a closed position. For example, if the topand bottom plates 26, 28 are squeezed together too tightly, damage mayoccur to the fluid holder 44 and flow through the fluid holder 44 may berestricted. If the top and bottom plates 26, 28 are not brought closelyenough together, heat transfer into and out of the fluid holder 44 maybe hindered. The first and second pins 50, 52 and the inlet and outletcouplings 53, 55 also ensure that the mounting sheet 60 and fluid holder44 mounted thereon cannot be disposed within the solid-state device 20in an incorrect orientation.

Still referring to FIG. 4 , the fluid holder 44 may include an inlettapered portion 57 and an outlet tapered portion 59, each coupling thefluid holder 44 to the respective inlet and outlet couplings 53, 55.Each of the inlet and outlet tapered portions 57, 59 also providegradual transitions between the inlet and outlet couplings 53, 55 andthe fluid holder 44, allowing the fluid holder 44 to expand as neededwhile still remaining tightly coupled to the inlet and outlet couplings53, 55. The inlet and outlet tapered portions 57, 59 help to increasethe surface area around the inlet and outlet couplings 53, 55 to whichthe fluid holder 44 may be connected, thereby allowing for a more robustattachment. The fluid holder 44 may be attached to the inlet and outletcouplings 53, 55 (i.e., at the inlet and outlet tapered portions 57, 59)via epoxy, adhesion, glue, sintering, fusion, compression fit, tapeand/or other suitable mechanisms. The connections and/or attachmentsbetween the fluid inlet and outlet 22, 24 and the inlet and outletcouplings 53, 55, as well as between the inlet and outlet couplings 53,55 and the fluid holder 44 need to be robust enough so that upon removalfrom the steady state device 20, the fluid holder 44 doesn't becomedetached from the fluid inlet and/or fluid outlet 22, 24, even if thefluid holder 44 is suspended from the fluid inlet and outlet 22, 24 andfilled with fluid.

Referring still to FIG. 4 , the mounting sheet 60 may include angledand/or tapered corners 54 at the end proximate the fluid inlet andoutlet 22, 24, which may aid in the insertion and/or removal of thefluid holder 44 within the solid-state device. The mounting sheet 60 mayalso include rounded corners 56 at the end opposite the fluid inlet andoutlet 22, 24. The bottom plate 28 may include a first recessed portion58 matching the general shape and thickness of the mounting sheet 60such that the mounting sheet 60 is easily received within the bottomplate 28. In operation, (i.e., while the solid-state device 20 is in theclosed position illustrated in FIG. 3 ) therapeutic fluid may flow intothe fluid holder 44 at the first portion 46 via the fluid inlet 22,around the rounded portion 45, toward the second portion 48, and outthrough the fluid outlet 24. Thus, fluid inlet 22 is fluidly coupled tothe fluid outlet 24 via the fluid holder 44.

Still referring to FIG. 4 , each of the first portion 46, the secondportion 48 and the rounded portion 45 are formed in the fluid holder 44via corresponding recesses and protrusions in the top plate 26. The topplate 26 includes recesses and protrusions (not shown) that define thefluid passageways in the fluid holder 44 that form when the fluid holder44 begins to fill, on account of fluid flowing therethrough. Statedotherwise, the fluid holder 44 itself does not include any fluidpassageways prior to insertion into the solid-state device 20. Thepassageways (i.e., the first portion 46, the second portion 48 and therounded portion 45) are formed in the fluid holder 44 as a result of thefluid holder 44 flexing around and conforming to the protrusions andrecesses in the top plate 26 (and bottom plate 28) when the solid-statedevice 20 is closed and therapeutic fluid is flowing through the fluidholder 44. Recesses and protrusions that define the fluid passageways inthe fluid holder 44 may be disposed within both the top plate 26 and/orthe bottom plate 28. FIG. 4 also illustrates a passageway center-wall 61which acts as a barrier defining the boundary between the passage wayfirst portion 46 and the second portion 48. Therapeutic fluid may flowaround the passageway center-wall 61 when the solid-state device 20 isin operation. The passageway center-wall 61 is formed in the fluidholder 61 as a result of a corresponding protrusion (not shown) in thetop plate 26 (the protrusion in the top plate 26 being surrounded byrecesses in the top plate 26 (and similarly on the bottom plate 28) thatdefine the fluid passageways within the fluid holder 44.

FIG. 5 illustrates a perspective view of an empty fluid holder 44 with afirst hole 64 disposed therethrough (through which the first pin 50 maybe inserted) as well as a second hole 62 disposed therethrough (throughwhich the second pin 52 may be inserted). In comparison to FIG. 4 (andalso FIG. 6 ), the fluid holder 44 of FIG. 5 is empty whereas the fluidholders 44 FIGS. 4 and 6 are full. In the embodiment of FIG. 5 , thefluid inlet 22 and fluid outlet 24 are disposed within the inlet andoutlet couplings 53, 55, which are connected to the fluid holder 44 viathe inlet and outlet tapered portions 57, 59. In the embodiment of FIG.5 , the mounting sheet 60 appears integral to (and monolithic with) thefluid holder 44. Stated otherwise, in some embodiments, the mountingsheet 60 is a continuous portion of the fluid holder 44 that does notend up forming (or becoming a part of) the fluid passageways that formonce the fluid holder 44 is placed in service within the solid-statedevice 20 (e.g., and the device is closed).

Referring still to FIG. 5 , in other embodiments, the mounting sheet 60(i.e., the portion of the fluid holder 44 at the edges and/or peripheryof the fluid holder 44) may have different material properties than thecenter portion of the fluid holder 44 such that the mounting sheet 60 isless flexible than the center portion of the fluid holder 44, therebymaking the fluid holder 44 easier to handle, more resistant to damage,and easier to insert within the solid-state device 20. In otherembodiments, the interior of the fluid holder 44 may be formed by twosheets of material (for example, polymer and/or thermoplastic material,among other possible materials) that are joined via a seam that extendsaround the periphery of the fluid holder 44. In this embodiment, theseam that extends around the periphery of the fluid holder 44 wouldinclude the first and second holes 62, 64 disposed therethrough, andwould allow for easy handling and insertion of the fluid holder 44 intothe solid-state device 20, as described above. The seam that extendsaround the periphery of the fluid holder 44 may be formed via anysuitable mechanisms for attaching the two sheets including (but notlimited to) adhesion, glue, epoxy, sintering and/or fusing. The fluidholder 44 and the connections between the fluid holder 44 and the fluidinlet and outlet 22, 24 may be constructed (and/or or composed ofsuitable materials) such that the fluid holder 44 remains airtight andaseptic at all times during operation, and also to ensure the fluidholder 44 does not get torn, ripped or punctured when in use and/orduring insertion or removal into and out of the solid-state device 20.

FIG. 6 illustrates a perspective view of a full fluid holder 44, as itwould appear with therapeutic fluid disposed therein, with the portionsaround the periphery of the fluid holder 44 (i.e., the mounting sheetportion) not filled with therapeutic fluid due to the protrusions withinthe top and bottom plates 26, 28 not allowing the fluid holder 44 toexpand in those areas. As discussed above, the fluid passageway that isformed within the fluid holder 44 around the passageway center-wall 61is defined by the recesses and protrusions in the top plate 26 andbottom plate 28 (in certain embodiments, recesses and/or protrusions maybe present in one or both of the top plate and bottom plate). A bottomperspective view (i.e., similar to the top perspective view of FIG. 6 )would accordingly illustrate a similar fluid passageway defined in theunderside of the fluid holder 44. The fluid holder 44, along with theinlet and outlet couplings 53, 55 as well as the fluid inlet and outlet22, 24 disposed therein may be preassembled and/or prefabricated suchthat each time the solid-state device 20 is used, a new preassembledfluid holder 44 can be placed within the solid-state device 20, thendisposed of afterward thereby eliminating the need to clean and/orsanitize either the solid-state device 20 or the fluid holder 44 (andmounting sheet 60). In the event that the solid-state device 20 requirescleaning or sterilization, the interior of the solid-state device can beeasily accessed by positioning the solid-state device 20 into the openconfiguration depicted in FIG. 4 (and FIG. 7 ). The fluid holder 44 maybe mounted on the mounting sheet 60 using any suitable means includingadhesion (e.g., epoxy), compression fit, and other suitable means. Inaddition, the fluid holder 44 and mounting sheet 60 may be integrallyformed and/or fabricated during the same continuous build or fabricationprocess such that the fluid holder 44 and mounting sheet 60 form asingle, integral, monolithic structure.

FIG. 7 illustrates a perspective view of the solid-state device 20without a fluid holder installed in it. The solid-state device 20includes a top plate 26, hingedly connected via one or more hinges 30 tothe bottom plate 28. Latches 44 keep the top plate 26 close to thebottom plate 28 when the solid-state device 20 is in a closed position.As discussed above, the top and bottom plates 26, 28 include top andbottom inlet and outlet recesses 32A, 32B, 34A, 34B to allow the fluidinlet and outlet 22, 24 to act as fluid conduits into and out of thesolid-state device 20. First and second pins 50, 52 (also as discussedabove) protrude upwardly from the top surface 29 of the bottom plate 28.

Still referring to FIG. 7 , the solid-state device 20 may include bottomplate recess 66 and a bottom plate protrusion 68 disposed within thefirst recessed portion 58 of the bottom plate 28. The first recessedportion 58 is recessed slightly from the top surface 29 of the bottomplate 28 to allow for the thickness of the mounting plate 60 and/orunfilled portions of the fluid holder 44. The bottom plate recess 66 isfurther recessed (i.e., from both the top surface 29 of the bottom plate28 as well as from the first recessed portion 58) to allow the fluidholder 44 to expand when it is inserted into the solid-state device 20and filled with therapeutic fluids, thereby defining the outerboundaries of the fluid passageways within the fluid holder 44. A bottomplate protrusion 68 extends upwardly from the bottom plate recession 66,thereby defining the passageway center-wall 61 (shown in FIGS. 4 and 6 )in the fluid holder 44 when the bag is in service within the solid-statedevice 20.

FIG. 8 illustrates a side view of the solid-state device 20 with the topplate 26 partially open and rotated about the one or more hinges 30.FIG. 8 illustrates the top inlet and outlet recesses 32A, 34A disposedwithin the top plate 26, as well as the latches 42 coupled to the topplate 26. In the embodiment of FIG. 8 , a second recessed portion 80 isrecessed slightly from a bottom surface 78 of the top plate 26 to allowfor the thickness of the mounting plate 60 and/or unfilled portions ofthe fluid holder 44 (i.e., when the fluid holder 44 is inserted in thesolid-state device 20). A top plate recess 70 is further recessed (i.e.,from both the bottom surface 78 of the top plate 26 as well as from thesecond recessed portion 80) to allow the fluid holder 44 to expand whenit is inserted into the solid-state device 20 and filled withtherapeutic fluids, thereby defining the outer boundaries of the fluidpassageways within the fluid holder 44. A top plate protrusion 72extends downwardly from the top plate recession 70, thereby defining thepassageway center-wall 61 (shown in FIGS. 4 and 6 ) in the fluid holder44 when the bag is in service within the solid-state device 20. FIG. 8also illustrates first and second pin holes 74, 76 disposed within thesecond recess portion 80 for receiving the first and second pins 50, 52when the solid-state device 20 is closed.

FIG. 9 illustrates a method 900 of heating and/or cooling a therapeuticfluid according to the present claimed embodiments. At step 902, themethod may include attaching fluid inlet and outlet tubes (not shown) tothe fluid inlet and outlet 22, 24. Step 902 allows the fluid holder 44to be fluidly coupled to a patient, dialysis system, blood warmingsystem and/or other equivalent system. At step 904, the method 900 mayinclude inserting the fluid holder 44 into the solid-state device 20. Atstep 924, the method 900 may include forming fluid passageways in thefluid holder 44 that are defined by recesses, contours, and protrusionsdisposed within the top and bottom plates 26, 28 (e.g., forming saidfluid passageways by closing the device, i.e., bringing the top andbottom plates together). At step 926, the method 900 may includeinitiating a flow of therapeutic fluid (such as blood or dialysate)through the fluid inlet 22, fluid holder 44, and fluid outlet 24. Atstep 928, the method 900 may include initiating heating and/or coolingwithin the top and bottom plates 26, 28 via one or more temperatureforcing device disposed therein, in order to adjust the temperature ofthe therapeutic fluid flowing through the solid-state device 20. Themethod 900 may include other steps and may skip steps detailed above. Inaddition, steps may be performed in a different order than what isillustrated in FIG. 9 . Additional steps may include stopping the flowof therapeutic fluid through the solid-state device 20, discontinuingthe heating and/or cooling within the solid-state device 20, opening thesolid-state device 20, removing the fluid holder 44, removing the tubingfrom the fluid holder 44, and disposing of the fluid holder 44. Inaddition, the method 900 may include several sub-steps to step 904(inserting the fluid holder 44 into the solid-state device) as detailedbelow.

Referring still to FIG. 9 , the method may include several sub-stepsthat ensure that the fluid holder 44 is installed correctly into thesolid-state device 20. Several of these sub-steps may not need to beperformed in many cases. According to method 900, these sub-steps mayinclude: at step 906 opening the top plate of the solid-state device 20;at step 908 aligning the fluid inlet and outlets 22, 24 with the firstand second recess 32B, 34B in the bottom plate 28; at step 910 aligningthe first and second holes 62, 64 in the fluid holder 44 with the firstand second pins 50, 52 on the bottom plate 26; at step 912 rotating thetop plate 26 partially closed via the one or more hinges 30; at step 914checking that the first and second recesses 32A, 34A on the top plate 26align with the fluid inlet and outlet 22, 24; at step 916 checking thatthe first and second pins 50, 52 align with the first and second pinholes 74, 76 on the top plate 26; at step 918, checking that the fluidholder 44 aligns with the recesses 58, 80 in the top and bottom plates26, 28; at step 920 closing the solid-state device 20; and at step 922,attaching the one or more latches 42. Several of the steps illustratedin FIG. 9 may be optional, skipped, and/or performed in a differentorder than what is illustrated in FIG. 9 .

The solid-state device 20 of the present embodiments eliminates the needfor a dedicated heat transfer fluid. The solid-state device 20 of thepresent embodiments heats and cools the therapeutic fluids directly orindirectly, thereby reducing and/or eliminating the risk of infectionattributed to the heat transfer fluid. In operation, the solid-statedevice 20 may include a maximum operating temperature from about 40degrees C. to about 60 degrees C., or from about 40 degrees C. to about50 degrees C., or from about 40 degrees C. to about 45 degrees C. Inoperation, the solid-state device 20 may accommodate a maximum flow rateof about 5 L/min (i.e., liters per minute) to about 15 L/min, or fromabout 7 L/min to about 13 L/min, or from about 9 L/min to about 12L/min, or from about 10 L/min to about 11 L/min. One source ofnosocomial pathogens in existing patient treatment devices is the heattransfer fluid, which has been eliminated from some embodiments of thesystem described in the present disclosure. In addition, the presentembodiments allow for the use of fluid holders 44 that do not havepredefined fluid passageways or channels within them. By allowing thefluid passageways to be defined in the fluid holder 44 via the recesses,protrusions and contours 58, 66, 68, 72, 78, 80 in the top and bottomplates 26, 28, a much simpler and easier to manufacture fluid holder 44may be employed. The hinge 30 connecting the top and bottom plates 26,28 makes inserting and removing the fluid holder 44 into and out of thesolid-state device 20 quick and easy, while also providing convenientaccess to the interior of the solid-state 20 device for cleaning andsterilizing operations.

FIG. 10 illustrates a temperature forcing device in a system for heatingand/or cooling a fluid, according to a illustrative embodiment. A bardisposed in the top plate of the temperature forcing device forms afluid path in a disposable bag placed in the device when the device isclosed. There is no fluid path defined when the device is open. In thisembodiment, thermoelectric Peltier heater/cooler components are depictedon both the top and bottom plates of the temperature forcing device.

FIG. 11 illustrates a view of the temperature forcing device of FIG. 10showing the inlet and outlet of the fluid path formed when the top andbottom plates are closed, with arrows illustrating direction of flowinto the channel formed.

FIGS. 12, 13, and 14 illustrates front, side, and top views of thetemperature forcing device of FIG. 10 , respectively.

FIG. 15 illustrates a flexible fluid holder (disposable bag) with afluid path formed by the temperature forcing device of FIG. 10 when thedevice is closed. FIG. 16 shows the bag in its normal state without afluid path formed (e.g., when not in the temperature forcing device ofFIG. 10 ).

FIG. 17 illustrates a direct fluid warming and/or cooling system withfluid flow provided by gravity, according to an illustrative embodiment.The fluid depicted is a therapeutic fluid. The fluid enters the inlet ofthe flexible fluid holder (disposable heat exchanger bag), with channelformed therein when the bag is placed between the top and bottom platesof the temperature forcing device (dry heater/cooler) and those platesare closed together. The fluid is heated and/or cooled by the dry heatercooler as it flows from the inlet to the outlet of the heat exchangerbag, then the fluid is delivered to the patient. At no time does thefluid directly contact the dry heater/cooler.

FIG. 18 illustrates a direct fluid warming and/or cooling system withpump assist, according to an illustrative embodiment. This system isidentical to that shown in FIG. 17 , except that a pump (here, aperistaltic pump) is depicted to assist flow of the therapeutic fluid(e.g., blood or IV solution) through the temperature forcing device. Atno time does the fluid directly contact the dry heater/cooler.

FIG. 19 illustrates a conditioned fluid warming and/or cooling system,according to an illustrative embodiment. Here, conditioned fluid from asupply is pumped through a reservoir (labeled “Belmont Convective FluidDisposable”) and into the disposable heat exchanger bag placed betweenthe top and bottom plates of a temperature forcing device (here, a dryheater/cooler). Upon heating and/or cooling by the temperature forcingdevice, the conditioned fluid flows through the outlet of the disposableheat exchanger bag and into connective tubing, for use as atemperature-controlled heat exchange fluid in another part of thesystem. At no time does the fluid directly contact the dryheater/cooler. Furthermore, the entire fluid flow path including thereservoir, the peristaltic pump (if used), the connective tubing, andthe heat exchanger bag, can be made to be disposable, further reducingcontamination risk.

In some embodiments, the system in accordance with the presentdisclosure comprises a component that directly, physically contacts thebody of a patient for managing a body temperature of the patient. Insome embodiments, the component is a blanket, a wrap, or a mattresscontaining the fluid. In some embodiments, the component may be wornover a portion of the patient's body. For example, the component may bedesigned so as to cover at least about 30%, 40%, or 50% of the body'ssurface. The system may stabilize the patient's body temperature, at adesired body core temperature. Such a component may have different formsdepending on its intended use. For example, the component may bedesigned for medical use, either for the purpose of reducing coretemperature (e.g., for a patient having a disease with a very highfever), for the purpose of increasing core body temperature (e.g., as ahyperthermia treatment, or after hypothermia treatment), or for both.

In some embodiments, the system may further comprise one or morethermometers or other temperature sensors for detecting the temperatureof the circulating fluid and/or the patient's body temperature. In someembodiments, a thermometer (or other temperature sensor) measurestemperature of the fluid as it enters the component (e.g., blanket, awrap, or a mattress). In some embodiments, a thermometer (or othertemperature sensor) measures an outlet temperature of the fluid as itexits the component (e.g., blanket, a wrap, or a mattress).

These and other features, aspects and advantages of the presentinvention will become better understood with reference to the followingdescription and appended claims. The accompanying drawings, which areincorporated in and constitute a part of this specification, illustrateembodiments of the present disclosure and, together with thedescription, serve to explain the principles of the present embodiments.

Certain Definitions

In order for the present disclosure to be more readily understood,certain terms are first defined below. Additional definitions for thefollowing terms and other terms are set forth throughout thespecification.

An apparatus, composition, or method described herein as “comprising”one or more named elements or steps is open-ended, meaning that thenamed elements or steps are essential, but other elements or steps maybe added within the scope of the composition or method. To avoidprolixity, it is also understood that any apparatus, composition, ormethod described as “comprising” (or which “comprises”) one or morenamed elements or steps also describes the corresponding, more limitedcomposition or method “consisting essentially of” (or which “consistsessentially of”) the same named elements or steps, meaning that thecomposition or method includes the named essential elements or steps andmay also include additional elements or steps that do not materiallyaffect the basic and novel characteristic(s) of the composition ormethod. It is also understood that any apparatus, composition, or methoddescribed herein as “comprising” or “consisting essentially of” one ormore named elements or steps also describes the corresponding, morelimited, and closed-ended composition or method “consisting of” (or“consists of”) the named elements or steps to the exclusion of any otherunnamed element or step. In any composition or method disclosed herein,known or disclosed equivalents of any named essential element or stepmay be substituted for that element or step.

As used herein, the term “patient” or “subject” (used interchangeablyherein) refers to any organism to which a provided composition is or maybe administered, e.g., for experimental, diagnostic, prophylactic,cosmetic, and/or therapeutic purposes. Typical patients include animals(e.g., mammals such as mice, rats, rabbits, non-human primates, and/orhumans). In certain embodiments, a patient is a human. In certainembodiments, a patient is suffering from or susceptible to one or moredisorders or conditions. In certain embodiments, a patient displays oneor more symptoms of a disorder or condition. In certain embodiments, apatient has been diagnosed with one or more disorders or conditions. Incertain embodiments, the disorder or condition is or includes bacterialinfection. In certain embodiments, the patient is receiving or hasreceived certain therapy to diagnose and/or to treat a disease,disorder, or condition.

As used herein, the term “substantially” refers to the qualitativecondition of exhibiting total or near-total extent or degree of acharacteristic or property of interest.

EQUIVALENTS

It is to be understood that while the disclosure has been described inconjunction with the detailed description thereof, the foregoingdescription is intended to illustrate and not limit the scope of theinvention(s). Other aspects, advantages, and modifications are withinthe scope of the claims.

This written description uses examples to disclose the invention,including the best mode, and also to enable any person skilled in theart to practice the present embodiments, including making and using anydevices or systems and performing any incorporated methods. Thepatentable scope of the present embodiments is defined by the claims,and may include other examples that occur to those skilled in the art.Such other examples are intended to be within the scope of the claims ifthey include structural elements that do not differ from the literallanguage of the claims, or if they include equivalent structuralelements with insubstantial differences from the literal languages ofthe claims.

1. A system for heating and/or cooling a fluid, the system comprising:at least one flexible fluid holder; a temperature forcing devicecomprising a bottom plate and a top plate hingedly coupled to the bottomplate, at least one of said bottom plate and said top plate comprising arecess or other area disposed therein or thereupon for receiving the atleast one flexible fluid holder, said at least one fluid holdercomprising a fluid inlet for receiving the fluid to be heated and/orcooled and a fluid outlet for delivering the heated and/or cooled fluidout of the temperature forcing device; wherein the at least one flexiblefluid holder and the temperature forcing device are arranged such thatthe fluid being heated and/or cooled does not directly contact thetemperature forcing device, thereby eliminating the need for the heaterto be sterilized. 2-4. (canceled)
 5. The system of claim 1, comprisingan entirely disposable fluid path, wherein the at least one flexiblefluid holder forms a portion of the entirely disposable fluid path.6-10. (canceled)
 11. The system of claim 1, wherein the temperatureforcing device comprises a solid state device. 12-14. (canceled)
 15. Thesystem of claim 1, comprising at least one fin disposed in at least oneof the bottom plate and the top plate.
 16. (canceled)
 17. The system ofclaim 5, wherein the at least one fluid holder is mounted to a mountingsheet, and wherein the mounting sheet forms a portion of the entirelydisposable fluid path. 18-35. (canceled)
 36. The system of claim 1,wherein the flexible fluid holder comprises: a plastic bag composed ofat least one of polyvinyl chloride (PVC), ethylene vinyl acetate (EVAM),polypropylene, and copolyester ether.
 37. The system of claim 1, whereinthe temperature forcing device comprises: a compressor.
 38. The systemof claim 15, wherein the temperature forcing device comprises: a blooddetector, at least one fluid temperature sensor, a pressure transducer,at least one patient temperature probe, an air detector, and/or a fluidflow rate detector; and a fan to increase a flow of air across the atleast one fin.
 39. The system of claim 1, wherein at least one of thefluid inlet and the fluid outlet further comprises: cylindrical tubingthat is fluidly connected to other system tubing and/or components viavarious connection mechanisms.
 40. The system of claim 39, wherein atleast one connection mechanism of the various connection mechanisms iscomposed of a material that is harder and/or more rigid than the fluidinlet and/or fluid outlet.
 41. The system of claim 15, wherein at leastone fin further comprises: a proximal portion disposed close to therespective top plate or bottom plate; a distal portion extending awayfrom the respective top plate or bottom plate; wherein the fin isthinner at the distal portion than at the proximal portion.
 42. Thesystem of claim 1, wherein at least one of the fluid inlet and the fluidoutlet further comprises: a tapered portion.
 43. The system of claim 17,wherein the mounting sheet further comprises: angled and/or taperedcorners at the end proximate the fluid inlet and fluid outlet.
 44. Thesystem of claim 17, wherein the mounting sheet comprises a continuousportion of the fluid holder that does not end up forming the fluidpassageways that form once the fluid holder is placed in service withinthe solid-state device.
 45. The system of claim 17, wherein the mountingsheet comprises different material properties than the center portion ofthe fluid holder.
 46. The system of claim 1, wherein: the fluid holdercomprises an interior; and the interior of the fluid holder is formed bytwo sheets of material that are joined via a seam that extends around aperiphery of the fluid holder.
 47. The system of claim 1, furthercomprising: at least one thermometer that measures temperature of thefluid as it enters the at least one flexible fluid holder; at least onethermometer that measures temperature of the fluid as it exits the atleast one flexible fluid holder.
 48. The system of claim 5, wherein thedisposable fluid path comprises a single-use disposable fluid path. 49.The system of claim 1, wherein the temperature forcing device does notneed to be maintained as sterile.
 50. The system of claim 1, wherein thetemperature forcing device is not sterilized before use.